A group-based programme for weight management (PROGROUP) versus usual care for weight management in adults with severe obesity
| ISRCTN | ISRCTN22088800 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN22088800 |
| IRAS number | 302670 |
| Secondary identifying numbers | CPMS 50790, IRAS 302670, NIHR201038 |
- Submission date
- 17/11/2021
- Registration date
- 02/12/2021
- Last edited
- 28/01/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Obesity affects one third of adults (about 15 million people) in the UK. Severe obesity reduces life expectancy due to potential development of diabetes, heart disease and cancer. People with severe obesity also report greatly impaired quality of life. The NHS provides specialised weight management services for people with severe obesity, known as Tier 3 services, but what the Tier 3 clinics do, and how effective they are is unclear. Our project seeks to better understand these clinics and investigate whether a new, group-based, support programme (called PROGROUP) is more effective and less costly than usual care.
Our principal objective is to conduct a randomised clinical trial of PROGROUP versus usual care in a relatively small number of people with severe obesity, to see whether it’s feasible to do so, and acceptable to participants. If we find that this feasibility trial is successful, we will then plan a larger, definitive, trial of the PROGROUP programme.
Who can participate?
Adults aged 18 years and over who are registered with the Tier 3 Weight Management Service and who have a BMI of at least 35, with a pre-existing medical condition or at least 40, without any other medical conditions.
What does the study involve?
Participants in the PROGROUP Intervention group will attend a group-based behavioural intervention, consisting of fifteen sessions over a 5-month period, with a member of the team (facilitator) at the specialist weight management clinic. The facilitator might be a nurse, dietician, or physiotherapist, each trained to provide this coordinated programme of support. Participants meet with the facilitator together, as a group of about twelve people. There are some one-to-one sessions with the facilitator. Over the 5-month period, participants will be shown various techniques to help make lasting changes to their behaviour or habits around eating and physical activity; and they will also be given guidance on nutrition and diet.
What are the possible benefits and risks of participating?
We don’t know yet if the PROGROUP intervention is effective; but those participants allocated to the PROGROUP intervention may find the sessions supportive. A special feature of PROGROUP is that participants meet with the facilitator together, as a group of about twelve people. When people develop a meaningful sense of social connection to other individuals, this can have a positive effect on behaviour change interventions in health care.
Trial procedures are non-invasive and pose no significant risk to participants. It’s possible that a participant may experience some emotional distress in a qualitative interview, if asked to think about their personal experiences. Qualitative interviews are conducted by experienced researchers trained to manage this, and other related issues, in the course of conducting the interviews.
Where is the study run from?
University Hospitals Plymouth NHS Trust (UK)
When is the study starting and how long is it expected to run for?
From May 2021 to May 2023
Who is funding the study?
National Institute for Health Research (NIHR) (UK).
Who is the main contact?
Dr Wendy Ingram
progroup.penctu@plymouth.ac.uk
Contact information
Scientific
Peninsula Clinical Trials Unit
N16 ITTC Building 1
Plymouth Science Park
Plymouth
PL6 1BX
United Kingdom
 ORCID ID |
0000-0003-0182-9462 |
|---|---|
| Phone | +44 (0)1752 439831 |
| progroup.penctu@plymouth.ac.uk |
Scientific
Community and Primary Care Research Group
N06 ITTC Building 1
Plymouth Science Park
Plymouth
PL6 8BX
United Kingdom
| ORCID ID |
0000-0003-1477-9935 |
|---|---|
| Phone | No telephone contact available |
| dawn.swancutt@plymouth.ac.uk |
Study information
| Study design | Interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A group-based behavioural intervention for weight management (PROGROUP) versus usual care in adults accessing NHS Tier 3 weight management services for treatment of severe obesity: a feasibility randomised controlled trial with parallel process evaluation and health economic evaluation |
| Study acronym | PROGROUP Feasibility RCT v1 |
| Study objectives | To test the feasibility of undertaking a randomised controlled trial of a group-based behavioural intervention for weight management (PROGROUP) versus usual care, in adults with severe obesity accessing NHS Tier 3 weight management services |
| Ethics approval(s) | Approved 01/11/2021, South West - Cornwall & Plymouth Research Ethics Committee (Level 3, Block B, Whitefriars, Lewins Mead, Bristol, BS1 2NT; +44 (0)2071048033/53; cornwallandplymouth.rec@hra.nhs.uk), ref: 21/SW/0144 |
| Health condition(s) or problem(s) studied | Severe obesity |
| Intervention | Patients who have been identified as potentially eligible for the study and who are about to have their first appointment at the NHS weight management service, or have recently had an initial appointment, will be provided with information about the study by the NHS staff. There are a couple of different points that the patient will be offered introductory information about the study. In all cases, patients will receive a short Study Summary Leaflet and a Participant Information Sheet (PIS), and a member of NHS staff will ask the patient if they are willing to be contacted about the study directly by a member of the PROGROUP research team. All patients approached will have the opportunity to discuss the study with a member of staff at the service or a member of the PROGROUP research team. Consent: Patients will be given at least 24 h to consider the PIS before being contacted by a member of the PROGROUP research team (only if the patient has given permission for direct contact). The researcher will review eligibility criteria with the participant and explain the study in further detail, addressing any queries raised by the patient, based on their reading of the PIS. If the patient is still willing to participate, informed consent will be taken, ether during the course of the telephone call, or may be rescheduled for a further call if preferred. Randomisation: Because the PROGROUP intervention is group-based, a sufficient number of participants are needed at each site to run the group. Recruitment will continue at the site until a cohort of sufficient size is reached. Only then will participants be randomised to PROGROUP (intervention) or usual care (control), but participants can expect to randomised within about 4 weeks (we will monitor this). Baseline assessments: Upon recruitment of a complete cohort (and randomisation), participants will be emailed a link to complete the online baseline questionnaire. Participants can request support from a researcher if needed. A reminder will be sent by email if participants have not completed the questionnaire (after 48 hours). If questionnaires remain uncompleted, researchers will contact participants to ascertain ongoing willingness to participate and to provide assistance if required. In the online questionnaire, participants are asked to provide information (using tick boxes) on: demographics, weight management history and co-morbidities (e.g. diabetes status). Participants are also asked to complete validated questionnaires: 1. Diet and physical activity, Adult Eating Behaviour Questionnaire and International Physical Activity Questionnaire (IPAQ) short form 2. Health-related quality of life, EQ-5D-5L questionnaire 3. Wellbeing, ICECAP-A, Self-esteem measure, Life satisfaction measure, Social Identification measure, Loneliness measure, and PHQ-4 4. Resource use questionnaire, use of health, social care, and wider societal resources Clinical measures are also recorded at baseline, i.e. participant height and weight, HbA1c (glycaemia measure) and lipids, and blood pressure. These will be collected as part of routine care at the initial visit to the weight management clinic. Receiving usual care: Participants allocated to the control group will receive usual care provided by the NHS weight management service. Receiving PROGROUP: Participants allocated to the intervention group will commence PROGROUP. In summary, the PROGROUP programme consists of 15 contact sessions in total, over 5 months, as follows: 1. Weeks 1-2: An initial one-to-one meeting: This will consist of a review of weight history, motivations for wanting to lose weight, establishment of an initial dietary and behaviour change programme, and preparations for joining the group. 2. Weeks 3-10: Eight consecutive, weekly group sessions: Each session will teach and build upon on behavioural skills of self-monitoring, problem solving, action planning and goal setting. These will be applied to dietary and physical activity behaviours. Each session will also contain nutrition and dietary advice/education. 3. Weeks 11-12: An interim one-to-one meeting. A review of progress, feedback on current behaviour and guided support and advice for progression in the programme, including potential goal revision. 4. Weeks 14-20: Four consecutive, fortnightly group sessions: This part of the programme reflects a ‘behavioural maintenance’ phase. Sessions focus on providing the toolkit for managing lapses, consolidating social support networks, making healthy food choices when eating out and during celebrations. 5. Weeks 21-22: A final one-to-one session. A review of progress. Clinical review to develop plans for individualised continuation of programme learning. Discussions about bariatric surgery or onward referrals or case management if necessary. The group sessions will be audio-recorded. Participants receiving the PROGROUP intervention will be asked to complete a session feedback form after each session, and pass this to the facilitator. PROGROUP participants will also be asked to complete an online questionnaire, at the beginning, middle and end of the intervention period, on ‘group processes’ such as social identification within the PROGROUP group. At 3 months, participants will complete the Wellbeing, Social Identification and loneliness self-reported measures online, in the same way described above for baseline: Once the 5 month intervention period at a given site has ended, a sample of amenable participants will be contacted for an in-depth interview (about 45 min long) with a researcher about their experience of the trial and trial processes, and all participants will be invited to complete a feedback questionnaire on a similar theme. Participants in the PROGROUP intervention, will transition to use care at the service, on completion of the intervention period. Follow-up at 6 and 12 months: At 6 months and 12 months, at a face-to-face visit at the weight management service, participant weight will be recorded. The results for blood tests for HbA1c (glycaemia measure) and lipids, and blood pressure, carried out as part of routine care will be recorded. Participants will complete the following self-reported measures online, in the same manner as described for baseline: 1. Co-morbidities 2. Diet and physical activity 3. Health-related quality of life 4. Wellbeing 5. Resource use questionnaire |
| Intervention type | Other |
| Primary outcome measure | 1. Recruitment rate is recorded as number of patients screened, consented (as a proportion of patients screened), and randomised (as a proportion of patients screened) at the time of screening and the time of randomisation 2. Retention rates are recorded as the number of recruited patients attending follow up visits at 6 and 12 months 3. Batch randomisation rate is measured as the time required to recruit enough participants within a site to trigger randomisation for a cohort at the time of randomisation 4. Data completeness for outcome measures and acceptability of outcome measures measured by recording number of completed self-report questionnaires and the number of missing items within a questionnaire at baseline, 3, 6, and 12 months 5. Acceptability of planned approach for longer-term follow-up measured using consent rates for additional follow-up data at 5 months 6. Fidelity of PROGROUP training and delivery assessed by fidelity assessment and iteratively refine delivery based on these assessments 7. Acceptability of trial processes and the intervention to the participants measured using intervention attendance rates and intervention engagement at baseline, 1-2, 3, 4, 5, 6, 7, 8, 9, 10, 11-12, 14, 16, 18, 20, and 21-22 weeks 8. Adherence to usual care measured by Tier 3 appointment attendances between baseline and 22 weeks |
| Secondary outcome measures | 1. Weight loss measured using weight at baseline, 6, and 12 months post-randomisation. 2. Percentage of participants achieving ≥5% weight loss measured using weight at baseline, 6, and 12 months post-randomisation 3. Percentage of participants achieving ≥10% weight loss measured using weight at baseline, 6, and 12 months post-randomisation 4. BMI derived from height at baseline and weight at baseline, 6, and 12 months post-randomisation 5. Diabetes risk/diagnosis of diabetes/control of diabetes measured using HbA1c at baseline, 6, and 12 months post-randomisation 6. Cardiovascular disease risk calculation measured using: 6.1. Blood Pressure at baseline, 6, and 12 months post-randomisation 6.2. Lipid profile measured using Total Cholesterol, HDL Cholesterol, and Triglyceride at baseline, 6, and 12 months post-randomisation 7. Change in alcohol use (non-validated) at baseline, 6, and 12 months post-randomisation 8. Change in Adult Eating Behaviour Questionnaire at baseline, 6, and 12 months post-randomisation 9. Change in International Physical Activity Questionnaire (IPAQ) short form at baseline, 6, and 12 months post-randomisation 10. Change in EQ-5D-5L questionnaire at baseline, 6, and 12 months post-randomisation 11. Change in ICECAP-A questionnaire at baseline, 6, and 12 months post-randomisation 12. Change in PHQ-4 questionnaire at 6 and 12 months post-randomisation. 13. Change in self-esteem and life satisfaction (non-validated) at baseline, 6, and 12 months post-randomisation 14. Change in health and social care resource use questionnaire at baseline, 6, and 12 months post-randomisation 15. Change in recorded comorbidities at baseline, 6, and 12 months post-randomisation 16. Change in use of relevant medications at baseline, 6, and 12 months post-randomisation 17. Change in social identification (non-validated) measure at baseline, 3, 6, and 12 months post-randomisation 18. Change in loneliness (non-validated) measure at baseline, 3, 6, and 12 months post-randomisation |
| Overall study start date | 01/05/2021 |
| Completion date | 12/09/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 96; UK Sample Size: 96 |
| Total final enrolment | 99 |
| Key inclusion criteria | 1. Body Mass Index ≥40 or ≥35 kg/m² with comorbidity 2 Aged ≥18 years 3. Willing to be randomised to either PROGROUP or usual care 4. Registered with the T3WMC 5. Considered suitable for group-based care 6. Have capacity to consent |
| Key exclusion criteria | 1. Currently engaged in any other weight management trial 2. Are scheduled to undergo bariatric surgery during the course of the trial 3. Unwilling or unable to attend group sessions 4. Intending to relocate outside the geographical region during the trial period 5. Participants who have significant difficulties in adequate understanding of English, or a sensory impairment, such that they are unable to sufficiently understand/access the trial documentation or engage in group sessions, in the absence of a local provision of translated materials or communication aids. |
| Date of first enrolment | 15/04/2022 |
| Date of final enrolment | 31/07/2022 |
Locations
Countries of recruitment
- England
- United Kingdom
- Wales
Study participating centres
College House
Heavitree Road
Exeter
EX1 2LU
United Kingdom
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom
Maes-y-coed Road
Cardiff
CF14 4HH
United Kingdom
Musgrove Park Hospital
Taunton
TA1 5DA
United Kingdom
Sponsor information
Hospital/treatment centre
Derriford Hospital
Derriford Road
Plymouth
PL6 8DH
England
United Kingdom
| Phone | +44 (0)1752 432842 |
|---|---|
| plh-tr.rdgovernance@nhs.net | |
| Website | http://www.plymouthhospitals.nhs.uk/home |
"ROR" |
https://ror.org/05x3jck08 |
Funders
Funder type
Government
No information available
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/05/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Intend to publish in an open-access peer reviewed journal . |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available after the research programme is published upon request from the Chief Investigator (CI), Prof Jonathan Pinkney, email: progroup.penctu@plymouth.ac.uk. Individual participant-level data that underlie the results will be available along with supplementary files as required (e.g. data dictionaries, blank data collection forms, analysis code, etc.). Data will be shared with (or access to the data will be provided to) applicants whose proposed use of the data has been approved by the CI and Sponsor, under an appropriate data sharing agreement. Consent to data sharing is obtained from participants. It will not be possible to identify individual participants from the data. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 10/09/2022 | 12/09/2022 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
28/01/2025: The intention to publish date was changed from 31/01/2025 to 31/05/2025.
28/11/2024: The intention to publish date was changed from 30/11/2024 to 31/01/2025.
09/10/2024: The intention to publish date was changed from 01/11/2024 to 30/11/2024.
28/06/2024: The intention to publish date was changed from 01/05/2024 to 01/11/2024.
08/09/2023: The overall trial end date has been changed from 01/09/2023 to 12/09/2023.
09/05/2023: The following changes have been made:
1. The overall trial end date has been changed from 01/05/2023 to 01/09/2023.
2. The final enrolment number has been added.
12/09/2022: Publication reference added.
14/06/2022: The recruitment end date was changed from 15/06/2022 to 31/07/2022.
14/03/2022: The following changes were made to the trial record:
1. The recruitment start date was changed from 15/02/2022 to 15/04/2022.
2. The recruitment end date was changed from 15/04/2022 to 15/06/2022.
10/01/2022: The recruitment start date was changed from 15/01/2022 to 15/02/2022.
17/11/2021: Trial's existence confirmed by the National Institute for Health Research (NIHR) (UK).
